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Improving Self-Monitoring in Weight Loss With Technology

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard behavioral treatment (SBT) for weight loss
SBT for weight loss using a PDA
SBT for weight loss using a PDA with feedback messages
Sponsored by
Lora Burke
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring technology in weight loss, standard behavioral therapy for obesity

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: age 18 to 59 years BMI ≥ 27 and ≤ 43 willing to be randomized to one of the three treatment conditions successful completion of screening Note that although residing in Western Pennsylvania is not an explicit eligibility criterion, participants are asked to travel to the University of Pittsburgh frequently. Exclusion Criteria: presence of an eating disorder current serious illness or unstable condition requiring physician-supervised diet and exercise including a glucose level above 125 at baseline physical limitations precluding ability to exercise pregnant or planning to become pregnant in the next 24 mos under current treatment for a psychological disorder reported alcohol intake of 4 drinks/day or more current or recent (past 6 mos) participation in a weight-loss program or use of weight-loss medication planning an extended vacation, absence, or relocation within the next 24 mos

Sites / Locations

  • University of Pittsburgh School of Nursing

Outcomes

Primary Outcome Measures

Weight Change

Secondary Outcome Measures

Adherence to self-monitoring
Coronary heart disease risk factors (lipid, glucose, insulin)

Full Information

First Posted
January 13, 2006
Last Updated
July 2, 2015
Sponsor
Lora Burke
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00277771
Brief Title
Improving Self-Monitoring in Weight Loss With Technology
Official Title
Improving Self-Monitoring in Weight Loss With Technology
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lora Burke
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We propose to conduct a randomized study of standard behavioral weight-loss treatment to test if using an electronic diary with or without tailored feedback will improve adherence to self-monitoring and subsequently improve weight loss. Subjects will be randomly assigned to different methods to self-monitor food and exercise habits: (1) use of the traditional paper diary , (2) use of a personal digital assistant (PDA), or (3) use of a personal digital assistant that also provides daily feedback.
Detailed Description
The prevalence of obesity, a major chronic health problem that is an independent risk factor for coronary heart disease (CHD), continues to increase at an alarming rate. Although weight control research has significantly improved short-term treatment success, long-term weight loss maintenance has lagged behind. Research has demonstrated a consistent relationship between self-monitoring eating and physical activity habits and success in weight loss as well as in maintenance of weight loss. However, the methods primarily used for self-monitoring continue to be the paper diary (PD), which is time consuming and burdensome. Moreover, PDs do not permit immediate external feedback to support and motivate the individual. Emerging technologies could improve self-monitoring and weight loss treatment. However, the use of these technological advances, such as a personal digital assistant (PDA), has not been studied in weight loss treatment. The primary aim of this behavioral weight loss treatment study is to determine if self-monitoring of daily eating and physical activity habits using a PDA, with or without a tailored feedback intervention, is superior to using a PD in terms of promoting and maintaining short- and long-term weight loss. Secondary aims include comparing the effect of treatment group assignment on adherence to self-monitoring and on risk factors for CHD (lipids, glucose, insulin, C-reactive protein). We propose to enroll 198 subjects and randomize them to one of three treatment groups that will use different methods to self-monitor eating and physical activity habits: (1) use of the traditional PD with delayed written feedback, (2) use of a PDA with limited feedback on daily targets, or (3) use of a PDA with limited feedback on daily targets plus receive daily, subject-tailored feedback messages via the PDA. The proposed study includes prolonged (24 months) supervision of self-management with three important components: self-monitoring, feedback, and ongoing contact. Subjects will complete assessments at baseline, 6, 12, 18, and 24 months. This innovative study will provide information on the efficacy of combining technological advances with proven behavioral strategies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
technology in weight loss, standard behavioral therapy for obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Standard behavioral treatment (SBT) for weight loss
Intervention Description
Participants attend group sessions where they learn about healthy eating and exercise. They are asked to self-monitor all calories consumed (food and drink) and all calories expended through exercise. Standard paper diaries are used for self-monitoring.
Intervention Type
Behavioral
Intervention Name(s)
SBT for weight loss using a PDA
Intervention Description
Participants attend group sessions where they learn about healthy eating and exercise. They are asked to self-monitor all calories consumed (food and drink) and all calories expended through exercise. Personal Digital Assistants (PDAs) are used for self-monitoring.
Intervention Type
Behavioral
Intervention Name(s)
SBT for weight loss using a PDA with feedback messages
Intervention Description
Participants attend group sessions where they learn about healthy eating and exercise. They are asked to self-monitor all calories consumed (food and drink) and all calories expended through exercise. Personal Digital Assistants with a customized feedback program are used for self-monitoring.
Primary Outcome Measure Information:
Title
Weight Change
Time Frame
Measured every 6 months
Secondary Outcome Measure Information:
Title
Adherence to self-monitoring
Time Frame
Measured throughout the study
Title
Coronary heart disease risk factors (lipid, glucose, insulin)
Time Frame
Measures annually

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 18 to 59 years BMI ≥ 27 and ≤ 43 willing to be randomized to one of the three treatment conditions successful completion of screening Note that although residing in Western Pennsylvania is not an explicit eligibility criterion, participants are asked to travel to the University of Pittsburgh frequently. Exclusion Criteria: presence of an eating disorder current serious illness or unstable condition requiring physician-supervised diet and exercise including a glucose level above 125 at baseline physical limitations precluding ability to exercise pregnant or planning to become pregnant in the next 24 mos under current treatment for a psychological disorder reported alcohol intake of 4 drinks/day or more current or recent (past 6 mos) participation in a weight-loss program or use of weight-loss medication planning an extended vacation, absence, or relocation within the next 24 mos
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lora E. Burke, PhD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh School of Nursing
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26609668
Citation
Goode RW, Ye L, Sereika SM, Zheng Y, Mattos M, Acharya SD, Ewing LJ, Danford C, Hu L, Imes CC, Chasens E, Osier N, Mancino J, Burke LE. Socio-demographic, anthropometric, and psychosocial predictors of attrition across behavioral weight-loss trials. Eat Behav. 2016 Jan;20:27-33. doi: 10.1016/j.eatbeh.2015.11.009. Epub 2015 Nov 14.
Results Reference
derived
PubMed Identifier
22936524
Citation
Turk MW, Elci OU, Wang J, Sereika SM, Ewing LJ, Acharya SD, Glanz K, Burke LE. Self-monitoring as a mediator of weight loss in the SMART randomized clinical trial. Int J Behav Med. 2013 Dec;20(4):556-61. doi: 10.1007/s12529-012-9259-9.
Results Reference
derived
PubMed Identifier
22704741
Citation
Burke LE, Styn MA, Sereika SM, Conroy MB, Ye L, Glanz K, Sevick MA, Ewing LJ. Using mHealth technology to enhance self-monitoring for weight loss: a randomized trial. Am J Prev Med. 2012 Jul;43(1):20-6. doi: 10.1016/j.amepre.2012.03.016.
Results Reference
derived

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Improving Self-Monitoring in Weight Loss With Technology

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